NCT00829231

Hepatic Impairment Study

Open Label, Phase 1 to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetic of Sorafenib ( BAY43-9006)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study is to find out how the subject's body processes and reacts to the study drug, and to find out how long it remains in the subjects system after one dose. Subjects with varying degrees of liver function are being asked to participate in this study. Study results from subjects with normal liver function will be compared with study results from subjects with impaired liver function.

Conditions

• Liver Disease

Interventions

Type	Name	Description
DRUG	Sorafenib (Nexavar, BAY43-9006)	Mildly Hepatic Impaired Subjects
DRUG	Sorafenib (Nexavar, BAY43-9006)	Moderately Hepatic Impaired Subjects
DRUG	Sorafenib (Nexavar, BAY43-9006)	Healthy Subjects

Timeline

• Start date: 2009-01-01
• Primary completion: 2009-07-01
• Completion: 2009-07-01
• First posted: 2009-01-26
• Last updated: 2014-11-03

Locations

3 sites across 1 country: United States